A new approach to estimating shelf-life

被引：12

作者：

Kiermeier, A

Jarrett, RG

Verbyla, AP

机构：

[1] Univ Adelaide, Biometr SA, SARDI, Glen Osmond, SA 5064, Australia

[2] CSIRO, Math & Informat Sci, Clayton, Vic 3169, Australia

来源：

PHARMACEUTICAL STATISTICS | 2004年 / 3卷 / 01期

关键词：

constraint; modified profile likelihood; quantile; shetf-life; stability analysis;

D O I：

10.1002/pst.78

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The current approach to the estimation of shelf-life and the determination of the label shelf-life as detailed in the International Conference on Harmonisation guidelines to industry is presented. The shortcomings of the status quo are explained and a possible solution is offered, which gives rise to a new definition of shelf-life. Several methods for calculating a label shelf-life are presented and investigated using a simulation study. Recommendations to adopt the new definition and to increase sample sizes are made. Copyright (C) 2004 John Wiley Sons Ltd.

引用

页码：3 / 11

页数：9

共 9 条

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